RAC DRUGS EXAM Questions with 100% Correct Answers

(EU) MA - Answer-Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA - Answer-National, centralised, mutual recognition, decentralized procedures MAH - Answer-A legal person or legal entity who must be established in the European Economic Area comprising of 28 member states. What does an MA include? - Answer-Active substance international non-proprietary name, trade name. SmPC - Answer-Summary of Product Characteristics PIL - Answer-Product Information Leaflet 6 months - Answer-How many months prior to expiration should MA renewal be submitted? Qualified Person (QP) in charge of? - Answer-Pharmacovigilance, scientific service in charge of each medicinal products scientific info ASMF - Answer-Active Substance Master File, info regarding the drug substance consists of one Applicants Part (AP), and one Restricted Part (RP), or proprietary information. CEP - Answer-Certificate of Suitability EDQM - Answer-European Directory for the Quality of Medicines CTD Module 1 - Answer-Region specific administrative data CTD Module 2 - Answer-Quality Overall Summary CTD Module 3 - Answer-Drug Substance and Drug Product Information CTD Module 4 - Answer-Nonclinical Study Reports CTD Module 5 - Answer-Clinical study reports DLP - Answer-Data lock point